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A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder

Investigating a Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03535129
Enrollment
101
Registered
2018-05-24
Start date
2018-09-20
Completion date
2025-03-23
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking Related Problems, Alcohol-Related Disorders, Healthy Volunteers

Keywords

Alcohol, Socioemotional, Functional Magnetic Resonance Imaging (fMRI), Neurofeedback, Drug Relapse

Brief summary

Background: Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person's social behavior and brain structure, but researchers don't have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking. Objectives: * To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. * To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking. Eligibility: * Adults ages 21 to 65 who have an alcohol use disorder. * Healthy volunteers ages 21 to 65 Design: Participants will be screened with * Physical exam * Medical history * Blood, urine, and heart tests * Mental health interview * Questions about their alcohol drinking. At each session, participants will have: * A urine test for drugs and pregnancy. If they test positive, they cannot participate. * A breath alcohol test and assessment for alcohol withdrawal. Participants will complete surveys, talk to researchers about behaviors, and play games. Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1-2 hours. Participants will do tasks in the scanner: * They will look at pictures, sometimes of alcohol. * They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else's changes. Participants may have follow-up phone questions at least 3 times over about 6 months.

Detailed description

Study Description: In the first stage, participants will undergo functional magnetic resonance imaging (fMRI) while looking at socioemotional stimuli and alcohol cues and will pilot a neurofeedback training protocol. Personality traits and executive function will also be investigated. This is the pilot stage that will be used to test and refine the neurofeedback parameters and procedure, and to compare neural responses and alcohol attention bias between participants with AUD and healthy controls. In the second stage, inpatient participants with alcohol use disorder will be randomly assigned to receive active or sham neurofeedback. Participants will undergo two functional magnetic resonance imaging sessions including looking at socioemotional stimuli and alcohol cues, resting state fMRI, and real time neurofeedback during alcohol craving. Ability to inhibit attention to alcohol cues and craving will be assessed prior to and following the neurofeedback as well. Participants will be contacted approximately 1 month, 3 months, and 6 months post release from inpatient treatment to assess outcomes. Objectives: The purpose of this protocol is to understand the mechanism whereby neural processes of socioemotional cognition associated with alcohol use disorders lead to negative drinking consequences. This study is a two-stage procedure to both provide evidence of a response modulation deficit associated with socioemotional processing in individuals with alcohol use disorder and investigate how moderating that deficit affects socioemotional processing and negative drinking consequences. Endpoints: Brain engagement during exposure to socioemotional stimuli, alcohol cues, and neurofeedback training (fMRI-scan portion)

Interventions

During fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION AND

Exclusion criteria

Stage 1: INCLUSION CRITERIA: 1. 21 to 65 years old 2. Healthy volunteers only: Consuming on average 7 or less standard drinks/week if female; 14 or less standard drinks/week if male (as determined by the most recent measurement within the past 90 days Alcohol Timeline Followback) 3. Alcohol use disorder (AUD) participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5) diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Attention Bias Signal - Stage 1On day of fMRI scanContrast in the estimated blood-oxygen-level-dependent (BOLD) response between the conditions of # 1) negative socioemotional cue paired with an alcohol cue, and #2) negative Socioemotional cue paired with a neutral cue during the fMRI brain scan. The contrast value was calculated by subtracting the BOLD response value for condition #1 from the BOLD response value from condition #2.
Change in Alcohol Craving - Stage 1On day of fMRI scanAlcohol craving was measured using a modified version of the Alcohol Craving Questionnaire Short Form (ACQ-SF-R). The ACQ-SF-R is a 12-item assessment measuring craving for alcohol among alcohol users in the current context. Each item is scored on the scale of 1 (strongly disagree) to 7 (strongly agree). The total general craving score is derived by summing the score of all 12 items, then dividing by 12. Higher score indicates higher craving. The change measure was calculated as craving measured prior to the fMRI scan subtracted from craving measured post-scan.
Change in Alcohol Attention Bias - Stage 2Week 4 - week 1Contrast in the estimated blood-oxygen-level-dependent (BOLD) response between the conditions of # 1) negative socioemotional cue paired with an alcohol cue, and #2) negative Socioemotional cue paired with a neutral cue during the fMRI brain scan. The contrast value was calculated by subtracting the BOLD response value for condition #1 from the BOLD response value from condition #2 for week one and week four. Analysis is the pre-post difference in BOLD contrast value from the pre-neurofeedback scan (week 1 scan) subtracted from the BOLD contrast value from the post-neurofeedback scan (week 4 scan).
Change in Alcohol Craving - Stage 2On day of scan during week 1 and week 4Alcohol craving was measured using a modified version of the Alcohol Craving Questionnaire Short Form (ACQ-SF-R). The ACQ-SF-R is a 12-item assessment measuring craving for alcohol among alcohol users in the current context. Each item is scored on the scale of 1 (strongly disagree) to 7 (strongly agree). The total general craving score is derived by summing the score of all 12 items, then dividing by 12. Higher score indicates higher craving. The change measure was calculated as craving measured prior to the fMRI scan subtracted from craving measured post-scan.
Mean Alcohol Craving Score1, 3, & 6 months after dischargeAlcohol craving was measured using a modified version of the Alcohol Craving Questionnaire Short Form (ACQ-SF-R). The ACQ-SF-R is a 12-item assessment measuring craving for alcohol among alcohol users in the current context. Each item is scored on the scale of 1 (strongly disagree) to 7 (strongly agree). The total general craving score is derived by summing the score of all 12 items, then dividing by 12. Higher score indicates higher craving. Analysis was done as the mean value for participants.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMelanie L Schwandt, Ph.D.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
101 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
34 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
50 Participants
Sex: Female, Male
Female
34 Participants
Sex: Female, Male
Male
18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 201 / 21
other
Total, other adverse events
0 / 300 / 301 / 201 / 21
serious
Total, serious adverse events
0 / 300 / 300 / 200 / 21

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026